MAUDE Adverse Event Report: AESCULAP AG ELAN 4 ELECTRO LOW SPEED MOTOR INTRA; PREVIOUSLY REPORTED

Model Number GA824

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problems Burn, Thermal (2530); Superficial (First Degree) Burn (2685)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product elan 4 electro lowspeed-motor intra.Specifically, it was reported that during an oral surgery, the drill became hot and burnt the patient's lip.It was the portion that the drill bit fits into.The patient's burn was treated with hydrocortisone.The purpose of the procedure was to correct an overbit; the jaw was cut in three places and moved out.An additional medical intervention was necessary.This event prolonged the surgery for 10 minutes while a new drill was brought into the room.The cord and console used in the procedure were used with a reciprocating saw without an issue.The adverse event is filed under reference (b)(4).Associated medwatch-report: 2916714-2020-00242.Involved components: gd450m - micro-line straight hdpc 1:1 f/2.35x70mm - serial no.(b)(4).

Manufacturer Narrative

Associated medwatches: 2916714-2020-00242, and 2916714-2020-00243.Reference code gd450m, device name micro-line straight hdpc 1:1 f/2.35x70mm, serial number n/a, batch number unknown, udi device identifier (b)(4), udi production identifier unknown, basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date unknown.Reference code ga824, device name elan 4 electro low speed motor intra, serial number n/a, batch number 52278515, udi device identifier (b)(4), udi production identifier unknown, basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date 15.11.2016.Failure description: gd450m.Optically, the handpiece is in a bad condition.Ga824.Optically, the motor is in a condition as expected after the period of use.Investigation: gd450m.The complained gd450m was manufactured in 2017.A repair or maintenance could not be found within our database.Optically and functionally the product is in a bad condition, the function cannot be checked.The interior is heavily contaminated, ball bearings, tool lock and tip are damaged and corroded.The staining occurred most likely due to an incorrect reprocessing and care.The complained ga824 with serial number #293 was manufactured in november 2016 and delivered in february 2017.A repair or maintenance could not be found within our database.Optically the ga824 is in a condition as expected after the period of use.During the functional test, running noises can be detected.Furthermore the ga806 connection cable became lose.In the dismantled state, contamination and corrosion became visible on various components such as ball bearings, stator and locking springs.The inner sleeve is broken.Considering the age, the listed deviations (except the inner sleeve) are due to normal wear.In the case of the inner sleeve, a handling error must be suspected.The device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.It is possible that the mentioned breakage of the ball bearing in combination with the staining led to the heating of the handpiece.A breakage of the ball bearings could be caused by an insufficient reprocessing or an overdue maintenance (wear and tear).Notes regarding the maintenance and checks can be found within the ifu.According to the (b)(4) report no capa is necessary.

Event Description

No updates.

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00268 (400476403 + ga824).Involved components: gd450m - micro-line straight hdpc 1:1 f/2.35x70mm - serial no.(b)(6).

Event Description

Associated medwatch-reports: 2916714-2020-00243 (400476403 + ga824), and 2916714-2020-00242.Involved components: gd450m - micro-line straight hdpc 1:1 f/2.35x70mm - serial no.2017 1006319.Additional information received via information from mw5095342: the patient was a six year-old female.The device was used a procedure for maxillary hypoplasia, mandibular hypoplasia, apertognathia and asymmetry.The patient underwent a lefort 1 segmental 3-piece osteotomy, bilateral sagittal split osteotomy and genioplasty.Upon using the ledemann bur, it was noted that the aesculap drill became very hot; during the removal of the drill from the patient's mouth, it was noted that the extension of the hand piece was hot and had burned the patient's lower right lip.Cold saline was placed on the lip immediately, and silver sulfadiazine was placed, and continued to be placed throughout the case.A new drill was requested and the procedure was successfully completed.After the procedure, the sterilization process was reviewed and no failures in the sterilization of the device were noted.

Manufacturer Narrative

Associated medwatches: 2916714-2020-00242, 2916714-2020-00243.Correction: this follow-up is being re-submitted with the correct mdr #.B5: information updated (also, lot # reported 001478 - not confirmed).

Event Description

19 year old female, white (previously reported as 6 year old female) - via mw (b)(4)additional information received.

• Brand Name: ELAN 4 ELECTRO LOW SPEED MOTOR INTRA
• Type of Device: PREVIOUSLY REPORTED
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10297687
• MDR Text Key: 200434402
• Report Number: 2916714-2020-00243
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 04046963793876
• UDI-Public: 4046963793876
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA824
• Device Catalogue Number: GA824
• Device Lot Number: 52278515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2020
• Distributor Facility Aware Date: 11/04/2020
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICRO-LINE STRAIGHT HDPC 1:1; MICRO-LINE STRAIGHT HDPC 1:1
• Patient Outcome(s): Required Intervention